DermacinRxâ€‹ Trizapak

Triamcinolone Acetonide Cream USP (0.1%)

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is:

CLINICAL PHARMACOLOGY

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions.

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

Patients should report any signs of local adverse reactions especially under occlusive dressing.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test

ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin Atrophy

Striae

Miliaria

OVERDOSAGE

DOSAGE AND ADMINISTRATION

Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Silapure™ Sheet
(silicone gel sheet)

IMPORTANT:

Apply Silapure™ Sheet to the skin for 4-8 hours to ensure no adverse reactions occur. Once a trial application is completed without adverse reaction, the Silapure Sheet may be applied to clean skin nightly before bed and removed each morning. Most treatment periods will last for two months. In case of serious skin conditions, continue using for 3-6 months or as directed by your physician.

Intended uses:

Flattens, softens and fades both existing and new hypertrophic scars or keloids.

How to use:

1) Open the bag and remove Silapure Sheet.

2) Cut the sheet to the size and shape of the affected skin area. If the skin area is larger, several sheets may be applied with edges aligned.

3) Remove the plastic film from the back of the sheet carefully and place the adhesive side onto clean skin. With good extensibility, it won’t tend to fall off. However, during sleeping or doing a lot of exercise, you can use a thin flex yarn tape or an adhesive tape to keep it in place.

4) Replace the sheet weekly or when it is no longer secure on the skin.

Cautions:

1) Stop use, in case of itching, blisters, or skin irritation.

2) Do not apply to the surgical wound until at least 1 week after suture removal.

3) Skin surface must be cleaned before use. Using this product on uncleaned skin surface or applying it with excessive tightness may result in roseola.

4) Product can be reused. If adhesive side is dirty, rinse with warm water and allow to be dried before reapplying.

5) The Silapure™ Sheet should not be shared with other individuals.

6) Do not use on unhealed or open wounds.

Store at room temperature and protect from sunlight.

Packaged in the USA by:PureTek Corporation
San Fernando, CA 91340
For questions or information